What side effects are associated with this type of intervention?

Common treatments for blood cancers, such as platinum-based chemotherapy, PARP inhibitors, elacytarabine, and hydroxyurea, have various side effects. Platinum-based chemotherapy can cause severe neutropenic toxicity, anemia, and gastrointestinal issues. PARP inhibitors are associated with hematologic adverse events like anemia, neutropenia, and thrombocytopenia. Elacytarabine can lead to febrile neutropenia, hypokalemia, fatigue, and other non-hematologic adverse events. Hydroxyurea's side effects include cytopenias, mucocutaneous ulcers, diarrhea, and potential severe pulmonary toxicity. Nicotinamide Riboside, while not a direct treatment for blood cancers, is being studied for its potential to improve metabolic outcomes and may have mild side effects such as nausea and gastrointestinal discomfort.

What prior FDA approvals exist?

FDA-approved treatments for blood cancers often include targeted therapies and chemotherapeutic agents. For example, venetoclax, a BCL-2 inhibitor, is approved for chronic lymphocytic leukemia (CLL) and acute myeloid leukemia (AML). Ivosidenib, an IDH1 inhibitor, is approved for AML with specific genetic mutations. While these treatments do not directly enhance NAD+ levels or target mitochondrial function like Nicotinamide Riboside, they represent the broader category of targeted therapies aimed at specific molecular pathways in blood cancers.

What other types of research exist?

Promising novel alternatives to Nicotinamide Riboside for blood cancer patients include combinations of hypomethylating agents (HMAs) with venetoclax or ivosidenib. Additionally, decitabine with sapacitabine and azacitidine plus gilteritinib are potential options.

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Exercise + Nicotinamide Riboside for Cancer Survivors with Insulin Resistance

N/A

Waitlist Available

Led By Rusha Bhandari

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least 18 years of age at time of enrollment

In remission at time of enrollment

Must not have

Currently taking medication for hyperglycemia or diabetes

Females who are pregnant or planning to become pregnant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial studies the effect of exercise and a vitamin-like supplement on muscle health and insulin resistance in adult survivors of childhood cancer with prediabetes. Participants will either do regular home exercise or do the same exercise while also taking a supplement similar to vitamin B3. The goal is to see if these interventions can improve their muscle health and how their body handles insulin.

Who is the study for?

Adult survivors of childhood cancer who are at least 18 years old, in remission for at least 6 months, and have prediabetes can join. They must be able to exercise at home using an online program, speak English, and sign a consent form. Those with pacemakers, recent NAD+ precursor use, diabetes medication use, MRI contraindications or current injuries cannot participate.

What is being tested?

The trial is testing the combination of exercise and a vitamin B3-like supplement called Nicotinamide Riboside on muscle health and insulin resistance in adults who survived childhood cancer but now face prediabetes. The goal is to find ways to improve their metabolic health.

What are the potential side effects?

Nicotinamide Riboside may cause mild side effects similar to those of vitamin supplements such as nausea or indigestion. Exercise might result in typical discomforts like muscle soreness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My cancer is currently in remission.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently on medication for high blood sugar or diabetes.

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I am currently pregnant or planning to become pregnant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Malignant Neoplasms

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (home exercise, nicotinamide riboside)Experimental Treatment2 Interventions

Patients complete home exercise as in Arm I. Patients also receive nicotinamide riboside PO daily for 6 weeks.

Group II: Arm I (home exercise)Active Control1 Intervention

Patients complete 18 home exercise sessions over 30 minutes each, 3 days per weeks for 6 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nicotinamide Riboside

2022

N/A

~160

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for blood cancers often target cellular metabolism and mitochondrial function, which are critical for cancer cell survival and proliferation. For instance, Nicotinamide Riboside enhances NAD+ levels, potentially improving mitochondrial function and insulin sensitivity. This is significant for blood cancer patients because cancer cells frequently rely on altered metabolic pathways for energy production and growth. By targeting these pathways, treatments can disrupt the cancer cells' energy supply, leading to reduced tumor growth and improved patient outcomes. This approach is particularly relevant for therapies aiming to exploit the metabolic vulnerabilities of cancer cells.

Mitochondrial metabolism as a potential therapeutic target in myeloid leukaemia.